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Regulatory and Start Up Specialist

2 hours, 22 minutes ago
France
Full-time
Mid Level
Compliance Manager
Project and Program Management
Apply Now
Precision Medicine Group

Precision Medicine Group

Precision Medicine Group specializes in precision medicine, utilizing targeted expertise and data insights to accelerate drug development and enhance the commercialization of next-generation medical products for the pharmaceutical and life sciences ind...

Pharmaceuticals
251-1K
Founded 2012
View All Jobs 152

Description

  • Prepare clinical trial application forms and submission dossiers for Competent Authorities, Ethics Committees, and other local bodies.
  • Manage initial and amendment/notification submissions within required timelines to support trial approvals.
  • Interact with Competent Authorities and Ethics Committees and handle their responses.
  • Provide regular status updates to the Start Up Lead, Regulatory Lead, Project Manager, and project team.
  • Maintain project plans, trackers, and regulatory intelligence tools for assigned responsibilities.
  • Support the development of study start-up plans, IMP release requirements, and essential document review criteria.
  • Partner with site CRAs to align communication and secure site review and management of essential documents for activation and IMP release.
  • Customize country- and site-specific Patient Information Sheets and Informed Consent Forms.
  • Coordinate translations of study documents and support document collection for site activation.
  • Serve as a subject matter expert on site activation critical path data, including regulatory timelines, site contracts, and budget negotiation requirements.
  • Support negotiation of study budgets and execution of investigator contracts when required.
  • Support feasibility activities, including site outreach to assess investigator interest in potential studies.
  • Maintain knowledge of local clinical trial laws and regulations and share updates internally as needed.
  • Maintain audit and inspection readiness and file documents in the Trial Master File according to study plans.
  • Support pre-study site visits when required.

Requirements

  • Bachelor’s degree in life sciences or a related field, ideally in a scientific or healthcare discipline, or Registered Nurse (RN), or equivalent education, training, and experience.
  • Pharmacy qualification or pharmacist work experience is highly beneficial.
  • Demonstrated experience as a Regulatory or Start Up Specialist, or in a comparable role, within a CRO, pharmaceutical, or biotech environment.
  • Strong communication and organizational skills.
  • Experience using computerized information systems, electronic spreadsheets, word processing, and email.
  • Fluency in English.
  • Relevant experience in regulatory and site start-up activities, including feasibility, contract negotiations, and CA/EC/IRB submissions, preferred.
  • Experience using milestone tracking tools or systems, preferred.
  • Ability to prioritize workload and meet deadlines, preferred.
  • Advanced degree in medical or life sciences such as MD, PhD, or PharmD, RAC certification, or a Master’s in Regulatory Science, preferred.

Benefits

  • Remote work option indicated by the #LI-Remote listing.
  • Equal Opportunity Employer status with non-discriminatory employment practices.
  • Reasonable accommodation support for applicants with disabilities during the application process.
  • Privacy policy and California applicant privacy notice provided for applicant data protection.

Interested in this position?

Apply directly on the company website

Apply Now

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